Actively Recruiting
Pharmacometrics Analysis of Rivaroxaban in Chinese Children Aged Over 2 Years
Led by Children's Hospital of Fudan University · Updated on 2025-05-29
60
Participants Needed
1
Research Sites
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Based on an established Kawasaki disease cohort database, this prospective, single-center, single-arm, observational study will collect clinical data from children aged 2 years and older with giant coronary artery aneurysms after Kawasaki disease who received rivaroxaban treatment. Rivaroxaban plasma concentrations, anti-factor Xa activity levels, and genetic polymorphisms will be measured and analyzed to support the population pharmacokinetic/pharmacodynamic analysis
CONDITIONS
Official Title
Pharmacometrics Analysis of Rivaroxaban in Chinese Children Aged Over 2 Years
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children aged 2 years to under 18 years
- Presence of giant coronary artery aneurysm(s) confirmed by two-dimensional echocardiography meeting criteria of Z-score ≥10 or internal diameter ≥8mm after acute Kawasaki disease
- Recommended anticoagulant with antiplatelet therapy for thromboprophylaxis for the next 6 months
You will not qualify if you...
- Active bleeding or bleeding risk that contraindicates anticoagulant therapy
- Hypersensitivity or other contraindications listed for rivaroxaban or comparator treatments
- Participation in other clinical drug trials at the same time
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Children's Hospital of Fudan University
Shanghai, Shanghai Municipality, China, 201102
Actively Recruiting
Research Team
F
Fang Liu, MD
CONTACT
G
Guangan Dai, MD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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